IV sets currently in the market typically uses a roller clamp or flow regulator to control flow rate. The use of a roller clamp is an economical way (only two plastic parts) of regulating flow rate by restricting a cross sectional area of the IV tube (by using roller and cam path from housing to pinch or release the tube). Unfortunately, it is time consuming for clinicians to set a desired flow rate because there are no markings on a roller clamp housing, and flow rate consistency changes over time due to the reaction forces from the IV tube to the roller clamp assembly.
However, even though flow regulators with dial markings have been used for clinicians to quickly set desired and more consistent flow rates, there are shortfalls with the use of known flow regulators as well. Since current flow regulators do not interact with tubes and typically function by diverting fluid flow into the flow regulator, unfortunately, this leads to a high tendency for leakage, as well as sterility issues. As such, current flow regulators typically have additional parts (such as elastomers) to provide seals which overcome the aforementioned issues. Consequently, this causes the cost of the flow regulator to be higher than the roller clamp due to use of more parts and a more expensive manufacturing process to assemble the higher number of parts.
In addition, the use of either the roller clamp or the flow regulator leads to a common problem of tampering with the roller clamp or the flow regulator by third parties. This could be fatal and at the very least, it results in incorrect dosage of the IV solution.
Even though there are flow regulators in the market which do provide a locking feature for a desired flow rate selected by clinicians, the locking feature is typically enabled with use of an additional part to carry out this locking function. This is typically an active lock that requires a user to lock/unlock before carrying out other functions such as flow rate selection. This clearly increases operation complexity, materials cost and manufacturing costs.
It is thus appreciated that there are issues with existing flow regulators in the market.